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Neoadjuvant Therapy for Stomach Cancer
Phase 1
Waitlist Available
Led By Dayssy A Diaz Pardo, MD, MS
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T1 N0 disease (assessed by endoscopic ultrasound)
Patient should be eligible for surgical intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 25 months
Awards & highlights
Study Summary
This trial is testing the safety of giving chemotherapy drugs followed by chemoradiation before surgery in treating patients with stomach or gastroesophageal junction cancer.
Who is the study for?
This trial is for adults with certain stages of stomach or gastroesophageal junction cancer, who are fit enough for surgery and chemotherapy. They should not have distant spread of cancer, severe neuropathy, or only one working kidney in the radiation area.Check my eligibility
What is being tested?
The study tests if giving chemotherapy (with drugs like docetaxel and oxaliplatin) followed by chemoradiation before surgery can safely shrink tumors in patients with gastric or gastroesophageal junction cancer.See study design
What are the potential side effects?
Possible side effects include reactions to chemotherapy such as nausea, fatigue, hair loss; nerve damage from drugs like oxaliplatin; and skin irritation or other issues related to radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is early stage and has not spread to lymph nodes.
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I am eligible for surgery.
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My cancer is a specific type of stomach or junction cancer that has not spread to distant organs.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I am eligible for specific chemotherapy treatments before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Number of patients able to complete all planned procedures and interventions successfully
Secondary outcome measures
18F-FDG dPET/CT to evaluate and characterize residual primary tumor following neoadjuvant chemotherapy and initial chemoradiation therapy for subsequent adaptive boost radiation delivery.
Overall survival (OS)
Perfusion and early tumor uptake kinetics of primary tumor using 8F-FDG dPET/CT approaches
+3 moreOther outcome measures
Standard uptake value SUVmax Tumor-to-liver metrics
Standard uptake value SUVmax metrics
Standard uptake value SUVpeak Tumor-to-liver metrics
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, chemoradiation, surgery)Experimental Treatment7 Interventions
NEOADJUVANT CHEMOTHERAPY: Patients receive FLOT chemotherapy consisting of docetaxel intravenously (IV) , oxaliplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on day 1 or FOLFOX chemotherapy consisting of oxaliplatin IV and leucovorin IV, and fluorouracil IV continuously over 24 hours on days 1 and 2. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.
NEOADJUVANT CHEMORADIATION: Within 4 weeks after completing neoadjuvant chemotherapy, patients undergo radiation therapy in 25 fractions over 5 weeks. Patients also receive either fluorouracil IV continuously for 24 hours on days 1-5 or capecitabine orally (PO) twice daily (BID) on days 1-5. Cycles repeat weekly for 5 weeks in the absence of disease progression or unacceptable toxicity.
SURGERY: Within 4-8 weeks after neoadjuvant chemoradiation, patients undergo surgical resection according to tumor location and per surgeon expertise.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved
Docetaxel
FDA approved
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Surgical Procedure
2016
Completed Phase 2
~150
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
316 Previous Clinical Trials
289,666 Total Patients Enrolled
Dayssy A Diaz Pardo, MD, MSPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is early stage and has not spread to lymph nodes.My cancer has spread to distant parts of my body.My nerve damage does not severely limit my daily activities.I am eligible for surgery.I have had or am recommended to have special scans to check my cancer stage before joining.My cancer is a specific type of stomach or junction cancer that has not spread to distant organs.I have only one working kidney that might be affected by radiation.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I am eligible for specific chemotherapy treatments before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (chemotherapy, chemoradiation, surgery)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the implications of radiation therapy on human health?
"Due to the minimal amount of existing data, Radiation Therapy received a score of 1 on our safety scale. This is because this trial is in its initial phase and researching efficacy and safety concurrently."
Answered by AI
Are there still opportunities to join this experiment?
"Clinicaltrials.gov indicates that recruitment for this trial has ended, as it was last updated on March 15th 2022. Although individuals can no longer join the study, there are 1,336 other medical studies actively seeking participants at present."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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